# K233308: Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Apr 25, 2024 after 209 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K983183 (1998). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143704: Advanced Air System, W&H Dentalwerk Buermoos GmbH (2015) Summary page 5.
- K162926: Air-Powered Handpieces and Handpiece Attachments, W&H Dentalwerk Burmoos GmbH (2017) Summary page 5.

## Indications for use
Air Motor is intended for the following application(s): Driving the handpiece for the tooth restoration, prophylaxis, and root canal preparation.

Source page: https://510kreport.com/device/K233308
Methodology: https://510kreport.com/methodology